Submission Details
| 510(k) Number | K810454 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 19, 1981 |
| Decision Date | March 04, 1981 |
| Days to Decision | 13 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
K810454 is an FDA 510(k) clearance for the HOMEMAKING UTENSILS, a Utensil, Homemaking (Class I — General Controls, product code IKW), submitted by Fred Sammons, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 4, 1981, 13 days after receiving the submission on February 19, 1981. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5050.
| 510(k) Number | K810454 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 19, 1981 |
| Decision Date | March 04, 1981 |
| Days to Decision | 13 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
| Product Code | IKW — Utensil, Homemaking |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 890.5050 |